Virologic, Lipid, Renal and Hepatic Laboratory Outcomes After Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Treatment-Experienced People with HIV: Real-World Evidence from the SHINe-SHIC Cohort.

Background/

Objectives

Doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) is used as a switch regimen in treatment-experienced people with HIV (PWH), particularly when simplification, lipid improvement, or avoidance of interaction-prone regimens is needed. We evaluated 48-week virologic effectiveness and laboratory changes after switching to DOR/3TC/TDF in routine care.

Methods

This multicenter retrospective study included adults with HIV who switched to fixed-dose DOR/3TC/TDF at seven Italian HIV centers within the Sardinian HIV Network-Sicilian HIV Cohort (SHINe-SHIC) network. The switch visit served as baseline; follow-up data were extracted at 24 and 48 weeks. The primary endpoint was HIV RNA < 50 copies/mL at 48 weeks in an observed analysis. Secondary endpoints were changes in lipid and lipid-derived parameters, renal function, and hepatic laboratory markers.

Results

Ninety-eight participants were included; 75 (76.5%) were male, and the median age was 52.4 years. At 48 weeks, 72/81 participants (88.9%) had HIV RNA < 50 copies/mL and 78/81 (96.3%) had HIV RNA < 200 copies/mL. Total cholesterol decreased from 199 to 165 mg/dL (median paired change, -22 mg/dL; p < 0.001), low-density lipoprotein cholesterol from 118 to 106.5 mg/dL (-13.5 mg/dL; p = 0.001), and triglycerides from 112.5 to 94 mg/dL (-10.5 mg/dL; p = 0.021). Non-high-density lipoprotein cholesterol and the total cholesterol/high-density lipoprotein cholesterol ratio improved, whereas high-density lipoprotein cholesterol decreased modestly. Serum creatinine and estimated glomerular filtration rate remained stable. Alanine aminotransferase increased modestly; aspartate aminotransferase and gamma-glutamyl transferase did not significantly change.

Conclusions

Switching to DOR/3TC/TDF maintained virologic control, improved lipid and lipid-derived parameters, and was not associated with renal function decline among participants with follow-up data. In selected treatment-experienced PWH, DOR/3TC/TDF may be useful when lipid improvement, simplification, or management of drug-drug interaction concerns are treatment goals.